Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures

NCT02805504 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 5160165
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries.

Conditions

Urinary Tract Diseases

Keywords

Bupivacaine; Minimally Invasive Surgical Procedures

Outcome Measures

Primary Outcomes (4)

• Total Opioid Consumption

  Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively

  Postoperative days 1-3

• Postoperative Pain Assessment

  Pain score (0-10) will be used. This will be based on a standard visual analog scale, where 0 indicates no pain and 10 indicates the most severe pain reported by patients.

  Postoperative day 1

• Length of Hospital Stay

  Duration of hospital stay after the surgery until time of discharge

  Duration of stay in hours

• Postoperative Complications

  Any complication related to the surgery within 30 days

  30 days postoperatively

Study Arms (2)

Exparel

EXPERIMENTAL

This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.

Drug: Exparel

Marcaine

ACTIVE COMPARATOR

This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.

Drug: Marcaine

Interventions

Exparel DRUG

This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.

Also known as: liposomal bupivacaine

Exparel

Marcaine DRUG

This group will receive intraoperative Bupivacaine HCl injection at the surgical site.

Also known as: Bupivacaine HCl

Marcaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing urologic surgery.

You may not qualify if:

• Pregnant and/or nursing mothers.
• Allergy to bupivacaine.
• History of drug/alcohol abuse.
• Severe cardiovascular, hepatic, renal disease or neurological impairment.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda Medical Center

Loma Linda, California, 92350, United States

Location

Related Publications (3)

• Abdelsattar JM, Boughey JC, Fahy AS, Jakub JW, Farley DR, Hieken TJ, Degnim AC, Goede W, Mohan AT, Harmsen WS, Niesen AD, Tran NV, Bakri K, Jacobson SR, Lemaine V, Saint-Cyr M. Comparative Study of Liposomal Bupivacaine Versus Paravertebral Block for Pain Control Following Mastectomy with Immediate Tissue Expander Reconstruction. Ann Surg Oncol. 2016 Feb;23(2):465-70. doi: 10.1245/s10434-015-4833-4. Epub 2015 Aug 26.

  PMID: 26307232 BACKGROUND

• Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.

  PMID: 26056753 BACKGROUND

• White S, Vaughan C, Raiff D, Eward W, Bolognesi M. Impact of liposomal bupivacaine administration on postoperative pain in patients undergoing total knee replacement. Pharmacotherapy. 2015 May;35(5):477-81. doi: 10.1002/phar.1587. Epub 2015 May 4.

  PMID: 25940854 BACKGROUND

MeSH Terms

Conditions

Urologic Diseases

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.

Results Point of Contact

• Title: Duane Baldwin, MD Director of Urologic Research
• Organization: Loma Linda University Health

dbaldwin@llu.edu

909 558 4196

Study Officials

• Mohamed Keheila, MD

  Loma Linda University Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 20, 2016
• Study Start: July 11, 2016
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: April 24, 2024
• Results First Posted: April 24, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)